Non-muscle Invasive Bladder Cancer Clinical Trial
Official title:
A Randomized Placebo Controlled Phase I/II Study Evaluating the Safety and Efficacy of alpha1H in Adult Patients With Non-muscle Invasive Bladder Cancer Awaiting Transurethral Surgery
This study evaluates the tolerability and preliminary anti-tumour effect of alpha1H in adults
with non-muscle invasive bladder cancer, who are awaiting transurethral surgery.
In the main, blinded part of the study, one group of subjects will receive treatment with
alpha1H and the other half will receive placebo. In a second, dose-escalation part of the
study, a third and fourth group of subjects will receive increased doses of alpha1H.
The treatment is given on 6 occasions during a period of 22 days. The study duration is 8 -
12 weeks including scheduled follow-up and up to 27 months when an optional 24-months
non-interventional follow-up period is included.
Protein-lipid complexes represent a new type of tumouricidal biologicals, with broad effects
against cancers of different origins. The investigational product alpha1H is a synthetic
peptide, corresponding to the alpha1 domain of α-lactalbumin, in complex with oleic acid.
Alpha1H is a further development product of HAMLET, a complex between human alpha-lactalbumin
and oleic acid, which has shown broad anti-tumor activity with a high degree of selectivity.
This study is a combined phase 1/2, placebo controlled, double blind study in subjects with
non-muscle invasive bladder cancer awaiting transurethral resection of bladder (TURB). The
first, main part of the study is randomized 1/1 and the subjects will receive intravesical
instillation of either alpha1H or placebo on 6 occasions during a period of 22 days (on days
1, 3, 5, 8, 15 and 22). In a second, open, dose-escalation (DE) part of the study, two
additional groups will receive increased doses of alpha1H in a standard 3+3 design in order
to determine a Maximum Tolerated Dose (MTD) or alternatively, a Maximum Administered Dose
(MAD). The same treatment schedule as in part 1 will be followed. One group will receive a
dose of 5 times the original dose and, if tolerated, the last group will receive a dose of 10
times the original dose.
Cell shedding is quantified and characterized at each treatment occasion. The bladder tumors
are characterized prior treatment and prior to the scheduled surgery. Remaining tumors will
be removed by TURB (according to European Association of Urology (EAU) Guidelines
recommendations) and tissues will be obtained for analyses.
A follow-up Visit will take place 30 days after the last administration of study treatment.
The total study duration of the main study is 8 - 12 weeks. After the main study, the
subjects may continue in an optional extended 24-months follow-up period.
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